Bachem seeks a Mid-level MES System Engineer in Stein AG to manage Körber PAS-X systems, supporting global IT and new facility startups in a hybrid role.
This position strengthens the Global IT team by leading the full lifecycle of the Körber PAS-X Manufacturing Execution System. The role is integral to Bachem’s long-term strategy to expand production capacity at a new site in Sisslerfeld, offering the chance to shape organizational structures during the project's design phase.
Responsibilities
- Oversee the complete lifecycle of the Körber PAS-X MES, covering design, configuration, deployment, validation, and ongoing improvements.
- Implement next-generation MES architectures that align with Pharma 4.0, smart manufacturing, and digital plant strategies.
- Guide MES activities throughout the new facility’s startup, from initial design and commissioning through to commercial manufacturing.
- Partner with manufacturing, automation, quality, and IT/OT teams to create scalable PAS-X solutions.
- Convert business and manufacturing process needs into detailed functional and technical MES designs.
- Maintain high system availability and performance in GMP-regulated environments, providing operational support as needed.
- Handle change control, incident management, and problem resolution in coordination with IT, operations, and vendors.
- Integrate PAS-X with enterprise and shopfloor systems, including ERP, LIMS, Historians, and automation platforms.
- Drive MES platform standardization and template strategies across global manufacturing sites.
- Ensure GMP-compliant documentation, including risk assessments, validation deliverables, and operational procedures.
- Serve as the MES Subject Matter Expert during audits, inspections, and regulatory interactions.
- Support computerized system validation (CSV/CSA) and qualification activities in line with GAMP5 and data integrity standards.
Requirements
- Bachelor’s or Master’s degree in Automation Engineering, IT, Computer Science, Pharmaceutical Engineering, or a related field.
- 4 to 6 years of hands-on experience with Körber PAS-X MES in regulated pharmaceutical or biotech settings.
- Proven track record supporting MES implementations for new facilities, expansions, or large digital transformation programs.
- Deep understanding of IT-OT architectures, system integrations, and smart factory concepts.
- Ability to administer a 24/7 operational MES system, ensuring reliability, performance, and disaster recovery readiness.
- Knowledge of system integration technologies, networking, virtualization, and cybersecurity within GMP environments.
- Experience with CSV/CSA, data integrity, and regulatory compliance, including GAMP5, Annex 11, and 21 CFR Part 11.
- Strong grasp of pharmaceutical manufacturing processes, commissioning, qualification, and operational readiness.
- Excellent stakeholder management and cross-functional collaboration skills.
- Strong analytical and problem-solving abilities in fast-paced project and operational contexts.
- Fluent English proficiency.
Nice to have
- Experience with PAS-X modules like electronic batch records (EBR), materials management, weigh & dispense, workflow design, and master batch record modeling.
- German language skills.
What the company offers
- A dynamic, rapidly growing work environment with internal development opportunities.
- Flexible working hours, home office days, and an option to earn extra vacation days through workload reduction.
- Employee development through numerous internal and external training opportunities.
- 60% coverage of pension fund contributions by Bachem, plus an option for extra-mandatory pension provision via the Pension Plan Plus.
- Access to a benefits platform with discounts from external partners.
About the company
Bachem is driven by continuous organic growth and is currently investing in a new planned site in Sisslerfeld, Northwestern Switzerland, to expand its production capacity.
- Investing in a new planned site in Sisslerfeld, Northwestern Switzerland, to expand production capacity.
- Driven by continuous organic growth.
How to apply
Documents to submit:
- complete application documents
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